Clinical Studies – Page 3 – Standing up to Parkinson's

Nearing its conclusion

I was scheduled to have my end of clinical trial Spinal Tap tomorrow, but since the doctor they take us to had them reschedule… I had mine a day early! The return ride ‘home’ i.e. back to Deland could have been responsible for giving me a headache, if one had developed. Gratefully, I was spared. But I have been hypersensitive to odors the last few days, and I held my sweater over my nose, the entire ride, because the perfume or car freshener seemed so offensive … assaulting my nostrils.

But YEA ! The Doctor learned from the last time and today, the Spinal Tap procedure was smoother and speedier…(I only jumped three times.) And it is done! Tomorrow, I’ll have a full day of blood tests, EKG and vital signs and the last dosing of the trial medication. Thursday is called my free day. They just hold us for observation. Friday, after vital signs and breakfast… we should be heading home. 🙂

One of the medics brought in a Wii for us to use for exercising. I am currently the champ. Last game I bowled 199. Far cry from real life. When I tried with the grandchildren a year ago… I think my final score was something like 38! I definitely needed the bumper rails up, to keep out of the gutter.

In anticipation of having other things needing my attention when we return home, I have been typing some posts, scheduling them to come out later in the month. When you go to the index, you see some topics that as yet have not been linked to a post. I am going to focus on addressing those topics. If you have a question or suggestion about something you’d like to see research on, please let me know.

Placebo or the Real deal

I have been baffled, because not every one in the study has the same restrictions on eating.

Where as I am not to eat for three hours prior to a dosing or half an hour after I take the pill, another test subject is required to go eleven hours without food and only eats twice a day.

Although we arrived for the study on the same day, they told him he had to wait an extra day to begin his dosing, because his medication hadn’t arrived from Belgium until then. (Weird)

{ I just noticed the rule: i before e, except after c doesn’t apply to the word weird…} (Weird)

Anyway, the study partner with the med from Europe (I’ll call him ‘E’) has been experiencing phenomenal improvements i.e. reductions in his symptoms.

When ‘E’ arrived, he used a cane, due to instability. soon he no longer felt a need for a cane, but he was still shuffling his feet. This morning, as I watched ‘E’walk down the hallway back to his room, ‘E’ was picking up his feet… an obvious confident walk with no shoe sliding!
It was ‘E’ who pointed out to me, that he could now snap his fingers. (When I tried snapping my fingers today, I could with one hand, barely.. but not the other… typical ups & downs of PD)
‘E’ reports he his speech & articulation are much improved.
‘E’ reports only a slight tremor in one hand remains.
‘E’ was excited this morning, to report he hadn’t drooled for the last two nights, as noted by the fact the sleeve of his sleeping attire had remained dry

As I visited with ‘E’ this morning, as we discussed the differences in our protocol, he suggested how I might determine if I was receiving the placebo. He said he didn’t swallow the capsule (cheeked it) then he allowed the capsule to dissolve in his mouth. Once was enough. His expectation was that if it was a sugar pill, it would be sweet. ‘E’ said what hit his taste buds was not sweet. Cautioning me to have water close, to wash the pill on down after it dissolved because what he had tasted horrible!

Naturally, I had to try it for myself. First off, it was not sweet… but it was nearly flavorless, but it did have a slight aftertaste. So… am I getting the placebo? or does ‘E’ have more keen taste? Do I have the test med, at a much lower dose? I’ll probably never know.

But what I do know, is there is something coming down the research pipeline that I hope will be available to turn back the symptoms… hopefully in the not too distant future.

Strange Happenings

I want to tell you about our sleeping quarters at the clinic where the Parkinson’s clinical trial is being conducted. There are 9 beds in the ward that John & I were assigned to. We could have our choice of beds. Wouldn’t you know… I picked a bed with a mind of its own?

We have individual curtains which could be pulled around for privacy, but no need. There are currently only 6 people here and with three wards, we have ours to ourselves. We are free to stay in our room, or sit in the dining room, or one of the two other rooms designated for TV watching, game playing, etc,

There is no specific time for waking up or retiring for the night. On the free days when there are only vital signs and pills to be taken, each participant has a few guidelines. For me, I am not to eat anything for three hours before they give me my dose (capsule) and I am not to eat anything for at least half-an-hour after dosing. I get my meds at 8:25 a.m [so breakfast is served at 8:55] Then the evening meal is served at 5:00 pm {I need to be through eating by 5:25} And my evening dose is 8:25.

I have read 3 novels & John is working on his third jigsaw puzzle. This is day 12 of the 30 day study.

On our first night here, I was pretty soundly asleep, when I heard the motor on the bed and it elevated my head slightly, and stopped. Due to my sleepiness, I didn’t rouse much. After the bed’s bizarre behavior had happened twice more, I had awakened sufficiently to recognize the need to trot to the little girl ‘s room. “What the?” When I returned and started to get into bed, the top half of the bed was all the way up! Perpendicular! As if sitting up straight!

The bed’s shenanigans had aroused John enough, that he thought I was having a hard time sleeping, not realizing I wasn’t in the bed, till I returned from the bathroom. We unplugged the bed, after coaxing it to lay back down.

When we reported the malfunction to the medic, Doug, in the morning, he related what had transpired, the last time the dorm had been used. The clinic had had a larger study going on and the room had been full of ladies. They had come running out of the room declaring one of the beds was possessed. He thought they were just messing with him, talking about poltergeist. The bed never acted out when he was in the room.

Doug had a good laugh, when John told him, ‘When he’d plugged the bed in, he’d noticed that the grounding prong was missing. So we’d figured that must account for the strange happenings.’

React with gratitude

The staff at the study site are doing their best… When I toured the facility, I asked if there was to be any exercise equipment, since an exercise regiem is considered to be the #1 most proactive thing Parkys should have. The medic said, “I understand they hae been ordered, but haven’t arrived yet.”

After my big data collecting day had passed, I asked, “Where is the exercise equipment.” After inquiring, the medic came to say, “There was a change in plans, and they have contracted with ..” “…. from an exercise gym, and they are supposed to have someone here tomorrow, to work with us in a group exercise class. They were a no show. 3rd time should be the charm, right? When they called to find out what happened? “… the person assigned just left on vacation… they will be here when they return.” REALLY?

I have been standing between two dorm beds. doing squats & leg lifts [ok,,a couple times] Then another study participant took matters in his own hands, saying he would like to organize a stretching exercise class. Today, I accepted an invitation to go out onto the patio for some stretching exercises to the accompanyment of ‘Oldies’ music.

After 12 minutes of exercise, he had us take three laps around the perimeter of the patio. This is where I stepped up, stating they should Swing their arms, while striding. Then, after swinging a little to music, our leader began to snap his fingers, demonstrating his RETURNED skill. Stating he hadn’t been able to snap previous to the start of the study.

Primarily this is done by building tension between the thumb and another (middle, index, or ring) finger and then moving the other finger forcefully downward so it hits the palm of the same hand at a high speed

I’m pleased to report I also have noted improvements. I wrote an address for John yesterday and he commented, “That is the most readable thing you have written for quite a while.” And knowing I had previously been unable to snap my fingers, I was delighted when I also could snap my fingers.. with both hands! This action precipitated conversation, with people telling me my face is more animated than when I arrived, and I smile.

Our exercise leader confided that one of the medics said they had seen a lot of improvement in him over the past week. I’m thinking it has been multiple strokes of good fortune that I learned of this study, that I was accepted to participate and I’m thinking did NOT receive the placebo.

There is the story of the alcoholic father with two sons. One follows in his father’s footsteps and ends up struggling through life as a drunk, and the other becomes a successful, sober businessman. Each are asked: “Why are you the way you are?” The answer for both is the same: “Well, it’s because my father was an alcoholic.” The same event, the same childhood, two different outcomes. This is true for almost all situations — what happens to us is an objective reality, how we respond is a subjective choice. The Stoics would say that we don’t control what happens to us, all we control are our thoughts and reactions to what happens to us. Remember that: You’re defined in this life not by your good luck or your bad luck, but your reaction to those strokes of fortune.

My reaction? Be grateful, not just in my heart, but EXPRESS GRATITUDE!

In good hands

As I’ve visited with the medics implementing the guidelines of the study, without exception, have seemed to me to be: caring, supportive, conscientious professionals, with prior paramedic &/or emergency trauma experience. One even maintains a job in Lady Lake, going on ambulance runs on the weekends.

I saw the Study Doctor again for a brief evaluation. Besides listening to my lungs he asked how things were going… and I reported I get hungry in the night. During the night, I had helped myself to four snacks. They will most likely be putting increased appetite as a ‘possible side effect.’ Which may not be a negative for me, since my last home scale reading was 105.

I do have to observe times for when I eat. Breakfast can’t be closer than 1/2 hour after dosing, And The evening meal has to happen at least 3 hours before the evening dose… so dinner at 5 to 5:30 prior to dosing at 8:30. It is no wonder I am hungry later… We haven’t been in the habit of eating our dinner before 8:30. BUT I think part of it also is the diet. When on Ketogenic diet, I didn’t get hungry. But, there is so much starchy foods and sugars here, I get full, but not satisfied.

Tonight, I held out half of my tuna sandwich and cherry pie in ziplock baggie, and put it in our room for when I wake up at midnight, 2:30 & 4:30 and can’t go back to sleep, till I eat something.

Running report

No, I’m not running away. And, actually, I haven’t been getting any exercise. I am just trying to create a continuing dialogue, to share my experience during the study.

They administer 1 dose, every 12 hours… 1/2 hr prior to breakfast & in the evening… so I have taken five capsules so far.

The process provides us with plenty of down time. After the Spinal tap and first day of blood draws, I have five days to rest. Day 6 is multiple blood draws, finger pricks and EKG. And if I understand correctly, there are another five days of rest, followed by another day of multiple blood draws, finger pricks and EKG. with the pattern following until the day of the second spinal tap which is expected to go very similar to the first day… except I trust the spinal tap will go more quickly. I haven’t asked if there is a weaning off of the meds period, but I know the last day, I’ll be meds free… but remain here just for observation. They are really cautious.

Yesterday, when I was transitioning from one room to another, the kitchen help saw me stumble/stagger and panicked. She talked to a tech and they said they were going to recommend I use a cane. Mind you… I have never fallen. Then, when the Main study doctor was doing a neurological exam on/with me today, he volunteered the opinion. As the medication builds up in my body, I should see a lessening of symptoms… so he opted to take a wait and see attitude.

I made the cut!

On June 21st, I told you I was being evaluated for a Parkinson’s study. I made the cut! I reported and settled in on Wednesday. Today, I am cutting and pasting from my report to our children about yesterday’s experience:

Yesterday, they took my husband/caregiver & I to Smyrna Beach, 45 minutes ride away for the spinal tap. I commented that I was surprised that they were taking us so far. Dr ‘D’ explained, ‘The office where we were going was the closest private Physician, who do spinal taps, they had been able to locate other than emergency rooms. They have an exam room set aside for the research group to use to follow the protocols for the specific study. So it was there, where they did pre-medication [ EKG, took vital signs and began extracting vials of blood and finger pricks and collection] Then I was given the morning DOSE. Then, at designated times, they did post-medication [ EKG, took vital signs and began extracting vials of blood and finger pricks and collection] 3 more times. Then two hours after taking the pill I was taken to a different room, where I met the Dr who did the spinal tap. Then, returning to the previous exam room. I was to spend an hour lying on my back. Then once again, [ EKG, took vital signs and began extracting vials of blood and finger pricks and collection] , before then returning to the research clinic in DeLand, where blood pressure, another vial of blood and finger prick collection were taken every two hours. four additional times.
I wanted to tell you about the spinal tap. There were several large rounded pieces of equipment… and attended by three or four additional attendants.. each wrapped in heavy led aprons. I was seated on an exam table encircled by it all… and asked to round my back. You can imagine my surprise, with the doctor’s first words…at first glance, “I see you have had back surgery.” I of course emphatically stated ‘No.. I had not!’ Then, upon closer examination, he marveled that the deep crevice running down my spine was a natural formation! He proceeded to use a local anesthetic and then attempt to thread a probe toward the target. I kept feeling pricks and other sensations on the left side of my spine, but felt nothing on the right side I think everybody (but me) were probably watching the monitor screens… which there were several of. The doctor kept saying ‘Sorry’ then he would poke some more .. then another ‘sorry.” After what seemed like at least twenty minutes, He said. “I’m going to have to try higher up. It is simply too tight, and I cant get in!” So someone cleaned my back, and they sanitized and administered more local anesthetic. After that, it went pretty quick.

Over all, I can’t complain about the spinal tap, because on a scale of 1 to 10, I’d say pain was only a 2. But, I couldn’t say my dignity/modesty was intact.

I may participate

I had a phone interview this morning. I passed the pre-qualifications and have an appointment tomorrow morning, at the clinic site in DeLand, to learn if I am accepted to participate in a study.

The study intrigues me, because …as I posted before, I have been taking an enzyme I found referenced to as beneficial in breaking down the build up of alpha-synuclein.

………………………….Serropeptase & Parkinson’s
12/29/18 Dr. Berg recommended … Serropeptase 3 x’s a day on empty stomach suggesting enzyme may break down or dissolve build-up of protein (alpha synuclein) in the brain.

I found this additional insight on ‘MyParkinsonTeam.com’: “Now known as Lewy bodies, these deposits of alpha-synuclein (aS) protein are understood to be one of the most common causes of dementia in people with parkinsonism.”

…………….I expect they will require that I discontinue taking the enzyme, for the duration of the trial… but that is ok.

STUDY PURPOSE: The most urgent unmet medical need in Parkinson’s disease is a treatment targeting the underlying disease mechanism and thus prevent the disease from progressing rather than only controlling symptoms. The study drug tested in this study is a new chemical compound called UCB0599, which could have such effects by preventing the aggregation of alpha-synuclein in the brain, which is thought to be the main driver of the disease progression. This is strongly supported by studies in animals but it is still unknown if UCB0599 will provide real benefit to humans. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple doses of UCB0599. Pharmacokinetics means measuring the amount of the study drug in the blood and how long it stays in the body. For this purpose, Study Participants will be randomly (by chance) assigned to receive either the study drug or a placebo, both provides as capsules. A placebo is a “dummy” capsule without UCB0599. Participation in this research will require participants to stay in a clinic or trial unit for 30 days (28 days of treatment and 2 days for safety follow-up). The study drug differs from purely symptomatic drugs currently available and may improve the medical care of patients who do not respond to, or cannot tolerate current drug treatments for Parkinson’s disease. The drug also has the potential to have a positive effect on a much broader range of symptoms of PD, including non-motor ones (like cognitive issues). The study is expected to provide critical safety and PK data required for a larger study to test if the drug works in PD patients.”

I will send updates to confirm if I am accepted.

Quietly Optimistic

I found this just tonight!! I have included the url to the whole report, of an Australian trial which gives new hope for Parkinson’s disease treatment… but cut and pasted sections for your convenience.

https://thenewdaily.com.au/life/wellbeing/2019/06/11/parkinsons-disease-treatment-trial/

“There’s quiet but confident hope for a breakthrough treatment for Parkinson’s disease, following a successful drug trial in Australia.”

“It ticked two boxes when it comes to treating the debilitating degenerative disease: Improved patient symptoms and it stopped the progression of Parkinson’s.”

………………………………..

The path to the phase-one trial results being released this week began about 15 years ago, Florey Institute head of neurotherapeutics Kevin Barnham said.

But even in those early days, Professor Barnham said, those involved were quietly optimistic. The positive results from the MND and Parkinson’s treatment trials have strengthened that optimism.

“So while it is still too early to claim definitive success, we’re doing the hard yards to discover exactly how the compound saves brain cells, and hope to report on this before the end of the year,” Professor Barnham said in a release on Tuesday.

………………………………………..

Nineteen Australian Parkinson’s patients were recruited for the trial, and 18 were administered the drug, in three different volumes: Small, medium and large.

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“I was playing it down to patients at the start, saying, ‘This probably won’t make you feel better’. But people were coming back saying, ‘I feel better on this drug’.”

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In Parkinson’s disease, some neurones are dead, and some are sick, while some remain functioning.

“What the drug has done is bring back those sick neurones into functioning well,” he said.